1. Field of the Invention
The present invention relates generally to surgical suturing apparatus and suturing procedures and, more particularly, to suture tie devices preferably and advantageously made of bioabsorbable materials that are particularly useful in endoscopic surgery, applicators for such suture tie devices, and methods of suturing using such suture tie devices.
2. Discussion of the Related Art
Suturing of bodily tissue is a time consuming part of most surgical procedures, including both open surgery and endoscopic or closed surgery. As used throughout this disclosure, the term "open" surgery relates to surgery wherein the surgeon gains access to the surgical site by way of a relatively large incision formed in the outer surface of the patient's body, whereas the terms "endoscopic" and "closed" surgery relate to surgery wherein the surgeon gains access to the surgical site by way of one or more relatively small portals formed in the outer surface of the patient's body through which one or more surgical instruments can be introduced to the surgical site. A variety of instruments, such as endoscopes, forceps, cutters, and applicators and the like, can be introduced through the portals to the surgical site. Commonly performed endoscopic surgical procedures include arthroscopy, laparoscopy (pelviscopy), gastroentroscopy, and laryngobronchoscopy.
Prior to the development of the subject suture device, suturing had been accomplished through the use of a sharp, curved metal suture needle attached to the end of a length of thread-like suture material. The surgeon or surgical attendant would extend the suture needle and trailing suture material through the tissue to be joined by the suture, after which the suture material would be tied into a knot and manipulated such that the knot could be advanced to the tissue site and adjusted for tension in order to accommodate the particular type of tissue being sutured and to control and account for approximation, occlusion, attachment, and other conditions of the tissue. The ability to control tension is extremely important to the surgeon regardless of the type of surgical procedure being performed; however, knotting of the suture material is time consuming and tedious work, particularly in microsurgery and endoscopic surgery. For example, suturing during microsurgery procedures is necessarily tedious and time consuming due to the reduced-size of the suture needle and suture material, and the concomitant difficulty in manipulating the reduced-size suture needle through the tissue and the tying of a knot in the suture material, all of which is performed by the surgeon while viewing the surgical site through various image magnifying devices. With respect to endoscopic surgery, suturing and tying knots represent an even more time consuming procedure due to the narrow confines of the endoscopic instruments. Accordingly, while endoscopic surgery would be preferred for many surgical procedures, the advantages are often outweighed by the disadvantages caused by the length of time required to complete the endoscopic surgical procedure, which time is greatly extended due to the difficulty and amount of time required for suturing.
There have been many attempts to provide devices to take the place of conventional suturing with a suture needle and a length of suture material. However, such prior art devices have essentially consisted of staples, clips, clamps, or other fasteners that do not provide the adjustability in tension that can be obtained by the surgeon incident knotting and advancing a length of suture material to the tissue to be sutured. U.S. Pat. Nos. 3,827,277 to Weston; 4,060,089 to Noiles; 4,490,326 to Beroff et al.; 4,513,746 to Aranyi et al.; 4,532,926 to O ' Holla; 4,548,202 to Duncan; 4,573,469 to Golden; 4,590,937 to Deniega; 4,595,007 to Meride; 4,602,634 to Barkley; 4,646,741 to Smith; 4,671,280 to Dorband et al.; 4,719,917 to Barrows et al; and 4,741,337 to Smith et al. are representative of such prior art devices for use in place of conventional suturing. Many of these prior art devices are made of bioabsorbable materials such that the devices are absorbed over time into the bodily tissue and do not have to be removed after the tissue has healed.
There exist many compositions useful as bioabsorbable materials, as represented by the above patents and by U.S. Pat. Nos. 3,739,773 to Schmitt et al.; 3,797,499 to Schneider; 4,141,087 to Shalaby et al.; 4,300,565 and 4,523,591 to Kaplan et al.; and 4,649,921 to Koelmel et al., which discuss characteristics of various bioabsorbable materials and medical devices desirably manufactured of such materials, such medical devices being of a type designed to be engaged in, embedded in, or otherwise attached to various types of bodily tissue, such as bone, muscle, internal organs, skin and other soft tissue, to remain in place in the tissue until the device is absorbed into the body.
U.S. Pat. Nos. 3,570,497 to Lemole discloses a suture device formed of a needle with a piercing point extending from a latch cord carrying notches designed to pass through a latch collar. The latch cord is resilient so as to be curved upon itself to form a suture stitch without requiring tying of knot. However, the latching function does not provide the same degree of tension control as can be obtained from knotting a length of suture material. U.S. Pat. No. 4,548,202 to Duncan discloses use of a similar structure in a tissue fastener device, in that serrations or angled barbs are provided along spaced legs passing through tissue to be engaged by an apertured receiver or a flexible filament mesh. U.S. Pat. No. 3,123,077 to Alcamo discloses a surgical suture device having raised projections, depressions or teeth such as barbs or spicules to snag or penetrate tissue so as to hold a sewn incision or wound.
Surgical clips and staples have also been proposed as substitutes for conventional suturing practices. Such clips and staples are used principally to ligate tubular bodies such as blood vessels during open surgical procedures, as well as for skin closure devices. However, these known structures have proven to be not entirely reliable ligating and tissue approximation devices, as the ends of the respective devices tend to separate over time, particularly when used in areas such as fluid vessels and skin folds where they are subjected to variations in pressure and/or tension.
Endoscopic surgery is generally preferred over open surgery due to the greatly reduced trauma and wound healing time for the patient, and due to the concomitant cost savings associated with shorter hospital stays and the ability to perform some forths of surgery without general anesthesia and in non-hospital or outpatient surgery sites. Accordingly, there has been much effort spent to develop techniques to facilitate suturing so as to further reduce the total duration of surgical procedures. Alternative suturing techniques that have been proposed have included electric coagulation, mechanical devices such as clips, clamps and staples, and lasers. However, no well-accepted alternative has yet been found, since suturing and tying are essential and vital parts of most surgical procedures due to the advantages discussed above with respect to the known alternatives. That is, to date, the proposed alternatives have had disadvantages which outweigh any benefits they may have conferred, chief amongst the disadvantages being an increased health and safety risk to the patient. Furthermore, these proposed suturing devices and procedures do not provide the surgeon with the advantages of suturing and tying and, as a whole, are not useful in a wide range of procedures to allow expansion of the areas in which endoscopic surgery can be effectively performed. Thus, there is a great need for new and advanced suture devices, particularly ones that are applicable in endoscopic surgery, that afford surgeons all of the advantages of knot tying and suture tensioning, and which can be applied in a time-efficient and effective manner.